FDA.reportPublic FDA data

VAROGuide PreGuide

Primary DI
08800038700093
Brand
VAROGuide PreGuide
Company
DMS Co., Ltd.
Model
PGS24
Published
2022-07-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800038700093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800038700093088000387000938800038700093

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688444000
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800038700000AnyCheckIMT-1002020-06-17
08800038700024VAROGuide PreGuidePGM132022-07-05
08800038700031VAROGuide PreGuidePGM242022-07-05
08800038700048VAROGuide PreGuidePGA2022-07-05
08800038700055VAROGuide PreGuidePGFL2022-07-05
08800038700062VAROGuide PreGuidePGFM2022-07-05
08800038700079VAROGuide PreGuidePGFS2022-07-05
08800038700086VAROGuide PreGuidePGS132022-07-05
08800038700109VAROGuide PreGuidePGUVRS2022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800076476356TruBite ScopeTruabutment Korea Co.,LtdNDP2026-11-03
08800076476486TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476493TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476509TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
08800076476516TruBoltTruabutment Korea Co.,LtdNDP2026-11-03
07290109308654Single TMA Snap-On TransferADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770031Depth Probe, Extra Long 16-25mmADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770246Single TMA Digital Model Abutment Replica, MachinedADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770314Guided UniFit Fixture Mount Screw Retained ScrewADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770383IRIS™, Burnout anti rotation cap red (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07290116770390IRIS™, Burnout cap white (4 pack)ADIN DENTAL IMPLANT SYSTEMS LTDNDP2026-11-01
07640169734823BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736056BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736063BiodentaBiodenta Swiss AGNDP2026-10-30
07640169736070BiodentaBiodenta Swiss AGNDP2026-10-30
07899995226273DRIVET RATCHET IMP. CM GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226280DRIVER RATCHET IMP. CM GUI. EST. MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226297DRIVER RATCHET IMP. CM GUIDEDSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226303DRIVER RATCHET IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226327DRIVER C.A. IMP. CM GUIDED NARROWSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995226587FIX. SURGICAL GUIDE PALATAL Ø2.0MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234315DEPTH PROBE GUIDED MOD. 02Sin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234384HELICAL DRILL Ø1.4MMSin Sistema de Implante Nacional S/ANDP2026-10-30
07899995234629GUIDED INITIAL DRILL Ø2.0X9MMSin Sistema de Implante Nacional S/ANDP2026-10-30
08050038833271RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833745RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833752RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833769RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833776RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30
08050038833783RealGUIDE Surgical Instruments3DIEMME SRLNDP2026-06-30